Bisoprolol in DMD Early Cardiomyopathy

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study aimed to use cardiac magnetic resonance imaging (CMR) to evaluate the efficacy and safety of bisoprolol therapy for boys with Duchenne muscular dystrophy(DMD) and preserved ejection fraction. On top of angiotensin-converting enzyme inhibitor (ACEI) , half of the participants will receive bisoprolol in combination, while the other half will not receive any beta-blocker.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Chinese Academy of Medical Sciences; National Natural Science Foundation of China
• Treatments: Bisoprolol

Criteria

Inclusion Criteria:

• Older than(including) 7 years old

• A definite diagnosis of DMD with muscle pathology confirming the expression of dystrophin lower than 5% and/or confirmed mutations in the DMD gene using a clinical accepted technique that completely defines the mutation.

• Using ACEI or ARB for more than 1 month

• Confirmed myocardial damage in one or more left ventricular segments evident by late gadolinium enhancement and preserved left ventricular systolic function(>45%) by cine cardiac MR in 45 days

• Normal renal function

• Holter and blood pressure shows no contraindication of using bisoprolol

Exclusion Criteria:

• Having metal implanted in body

• Having claustrophobia

• Allergic to gadolinium

• Complicated with other cardiovascular diseases

• Medical history or Holter show bradyarrhythmia like II/III degree atrioventricular block, sick sinus syndrome etc.

• Systolic blood pressure lower than 90mmHg or rest heart rate lower than 75bpm

• Having COPD or asthma history

• Having other complications: tumor, endocrine diseases

• Having beta blockers therapy

• Planned operation in the future 12 months

• Allergic to bisoprolol